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Article ; Online: Long-term Safety and Tolerability of Repeated Treatments With OnabotulinumtoxinA in Children With Neurogenic Detrusor Overactivity.

Franco, Israel / Hoebeke, Piet B / Dobremez, Eric / Titanji, Wilson / Geib, Till / Jenkins, Brenda / Yushmanova, Irina / Austin, Paul F

The Journal of urology

2023 Volume 209, Issue 4, Page(s) 774–784

Abstract: Purpose: OnabotulinumtoxinA is an approved treatment for neurogenic detrusor overactivity in adults inadequately managed with anticholinergics, and more recently was approved in children on the basis of a phase 3, 48-week, single-treatment study ( ... ...

Abstract	Purpose: OnabotulinumtoxinA is an approved treatment for neurogenic detrusor overactivity in adults inadequately managed with anticholinergics, and more recently was approved in children on the basis of a phase 3, 48-week, single-treatment study (NCT01852045). Given the paucity of long-term pediatric data, we report on the continued safety in these patients after repeated onabotulinumtoxinA treatment. Materials and methods: This was a multicenter, double-blind, repeat-treatment extension study (NCT01852058) in patients who entered from the preceding single-treatment study. Data were integrated across both studies. All patients (5-17 years) used clean intermittent catheterization and could receive dose escalations based on response to preceding treatment (50 U, 100 U, or 200 U onabotulinumtoxinA [not to exceed 6 U/kg]). Results: Overall, 95, 90, 55, and 11 patients received 1, 2, 3, and 4 treatments with onabotulinumtoxinA, respectively, and median (quartiles) duration of follow-up was 82 (65, 94) weeks. The safety profile was similar across doses and after repeat treatments. The most common treatment-emergent adverse event during cycles 1, 2, and 3 was urinary tract infection (31%, 34%, 22%). Three serious treatment-emergent adverse events related to study treatment (3/95; 3.2%) were reported during the study, which were all cases of urinary tract infection. Annualized urinary tract infection rates post-treatment were similar to pre-screening rates. There were no cases of autonomic dysreflexia, neutralizing antibodies, and treatment-emergent adverse events related to distant spread of toxin. Conclusions: OnabotulinumtoxinA continued to be well tolerated after repeated treatments in pediatric neurogenic detrusor overactivity patients with similar safety profiles across dose groups. Treatment-emergent adverse events were primarily urological with no new safety concerns.
MeSH term(s)	Adult ; Humans ; Child ; Botulinum Toxins, Type A ; Treatment Outcome ; Urinary Bladder, Overactive/drug therapy ; Urinary Tract Infections/drug therapy ; Double-Blind Method ; Urinary Bladder, Neurogenic/drug therapy
Chemical Substances	Botulinum Toxins, Type A (EC 3.4.24.69)
Language	English
Publishing date	2023-01-19
Publishing country	United States
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3176-8
ISSN	1527-3792 ; 0022-5347
ISSN (online)	1527-3792
ISSN	0022-5347
DOI	10.1097/JU.0000000000003157
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Article ; Online: Reply by Authors.

Franco, Israel / Hoebeke, Piet B / Dobremez, Eric / Titanji, Wilson / Geib, Till / Jenkins, Brenda / Yushmanova, Irina / Austin, Paul F

The Journal of urology

2023 Volume 209, Issue 4, Page(s) 783–784

Language	English
Publishing date	2023-04-01
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	3176-8
ISSN	1527-3792 ; 0022-5347
ISSN (online)	1527-3792
ISSN	0022-5347
DOI	10.1097/JU.0000000000003157.03
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Article ; Online: Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions.

Evans, Robert / Kohan, Alfred / Moldwin, Robert / Radecki, Daniel / Geib, Till / Peters, Kenneth M

Neurourology and urodynamics

2021 Volume 40, Issue 7, Page(s) 1730–1739

Abstract: Aims: Two phase 2 studies were conducted to assess the efficacy and safety of lidocaine-releasing intravesical system (LiRIS) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) with (Study 001; NCT02395042) or without, (Study 002; ... ...

Abstract	Aims: Two phase 2 studies were conducted to assess the efficacy and safety of lidocaine-releasing intravesical system (LiRIS) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) with (Study 001; NCT02395042) or without, (Study 002; NCT02411110) Hunner lesions (HL). Methods: Both were multicenter, randomized, double-blind, placebo-controlled, and enrolled women aged ≥18 years. In Study 001, patients were randomized 2:1:1 to LiRIS 400 mg/LiRIS 400 mg, placebo/LiRIS 400 mg, or placebo/placebo for a continuous 28 (2 × 14)-day period. In Study 002, patients were randomized 1:1 to LiRIS 400 mg or placebo for a continuous (single treatment) 14-day period. Results: In total, 59 and 131 patients received treatment in Studies 001 and 002, respectively. There was no statistically significant difference in the primary endpoint, the change from baseline to Week 4 of follow-up post-removal in mean daily average bladder numeric rating scale (NRS) pain score in either study (Study 001: placebo/placebo, -1.6; LiRIS/LiRIS, -2.7, p = 0.142; placebo/LiRIS, -2.5, p = 0.319; Study 002: LiRIS -1.2; placebo, -1.5, p = 0.505). There was no statistically significant difference between groups in daily worst NRS pain score, number of micturitions/day or urgency episodes/day. There was no clear trend for reduction in number of HL for LiRIS vs placebo. The frequency of treatment-emergent adverse events was similar between treatment groups in both studies; most were mild or moderate intensity. Conclusion: These studies did not demonstrate a treatment effect of LiRIS 400 mg compared with placebo, either in patients with IC/BPS with HL, or in those without HL.
MeSH term(s)	Adolescent ; Adult ; Cystitis, Interstitial/diagnosis ; Cystitis, Interstitial/drug therapy ; Double-Blind Method ; Female ; Humans ; Lidocaine/adverse effects ; Pelvic Pain ; Treatment Outcome
Chemical Substances	Lidocaine (98PI200987)
Language	English
Publishing date	2021-07-20
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	604904-7
ISSN	1520-6777 ; 0733-2467
ISSN (online)	1520-6777
ISSN	0733-2467
DOI	10.1002/nau.24702
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Article ; Online: Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence.

Chermansky, Christopher J / Richter, Holly E / Jacoby, Karny / Titanji, Wilson / Jenkins, Brenda / Geib, Till / Brucker, Benjamin M

The Journal of urology

2022 Volume 208, Issue 4, Page(s) 855–862

Abstract: Purpose: Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation ... ...

Abstract	Purpose: Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture. Materials and methods: After review of a stage 1 safety phase by an independent committee, participants were recruited into stage 2 and randomized to either onabotulinumtoxinA 100, 300, 400, or 500 U, or placebo, all with hydrogel admixture. End points included change from baseline to week 12 in the number of urinary incontinence episodes (primary); micturition, urgency urinary, and nocturia episodes/day; volume voided per micturition; proportion of participants with a ≥50% decrease from baseline in urinary incontinence episodes/day; and Overactive Bladder Questionnaire total score. Adverse events were reported. Results: Change from baseline to week 12 in number of urinary incontinence episodes was -2.72 with placebo and ranged from -0.89 to -1.85 in the onabotulinumtoxinA + hydrogel treatment groups. No difference from placebo was observed for any efficacy end point. The proportions of participants with treatment-emergent adverse events were similar among all groups, with asymptomatic bacteriuria the highest reported (6.7%-15.5%). There were no reports of urinary retention or elevated post-void residual volume. Conclusions: Intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of refractory overactive bladder was well tolerated, but it showed no improvement over placebo.
MeSH term(s)	Administration, Intravesical ; Adult ; Botulinum Toxins, Type A ; Humans ; Hydrogels ; Quality of Life ; Treatment Outcome ; Urinary Bladder, Overactive/complications ; Urinary Bladder, Overactive/drug therapy ; Urinary Incontinence/drug therapy
Chemical Substances	Hydrogels ; Botulinum Toxins, Type A (EC 3.4.24.69)
Language	English
Publishing date	2022-07-05
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	3176-8
ISSN	1527-3792 ; 0022-5347
ISSN (online)	1527-3792
ISSN	0022-5347
DOI	10.1097/JU.0000000000002800
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Article ; Online: OnabotulinumtoxinA for the treatment of neurogenic detrusor overactivity in children.

Austin, Paul F / Franco, Israel / Dobremez, Eric / Kroll, Pawel / Titanji, Wilson / Geib, Till / Jenkins, Brenda / Hoebeke, Piet B

Neurourology and urodynamics

2020 Volume 40, Issue 1, Page(s) 493–501

Abstract: Aims: This study evaluated whether one (or more) of three doses of onabotulinumtoxinA were safe and effective to treat neurogenic detrusor overactivity (NDO) in children.: Methods: This was a 48-week prospective, multicenter, randomized, double-blind ...

Abstract	Aims: This study evaluated whether one (or more) of three doses of onabotulinumtoxinA were safe and effective to treat neurogenic detrusor overactivity (NDO) in children. Methods: This was a 48-week prospective, multicenter, randomized, double-blind study in children (aged 5-17 years) with NDO and urinary incontinence (UI) receiving one onabotulinumtoxinA treatment (50, 100, or 200 U; not to exceed 6 U/kg). Primary endpoint: change from baseline in daytime UI episodes. Secondary endpoints: change from baseline in urine volume at first morning catheterization, urodynamic measures, and positive response on the treatment benefit scale. Safety was also assessed. Results: There was a similar reduction in urinary incontinence from baseline to Week 6 for all doses (-1.3 episodes/day). Most patients reported positive responses on the treatment benefit scale (75.0%-80.5%). From baseline to Week 6, increases were observed in urine volume at first morning clean intermittent catheterization (50 U, 21.9 ml; 100 U, 34.9 ml; 200 U, 87.5 ml; p = 0.0055, 200 U vs. 50 U) and in maximum cystometric capacity (range 48.6-63.6 ml) and decreases in maximum detrusor pressure during the storage phase (50 U, -12.9; 100 U, -20.1; 200 U, -27.3 cmH Conclusions: OnabotulinumtoxinA was well tolerated and effective for the treatment of NDO in children; 200 U showed greater efficacy in reducing bladder pressure and increasing bladder capacity.
MeSH term(s)	Adolescent ; Botulinum Toxins, Type A/pharmacology ; Botulinum Toxins, Type A/therapeutic use ; Child ; Child, Preschool ; Double-Blind Method ; Female ; Humans ; Male ; Prospective Studies ; Treatment Outcome ; Urinary Bladder, Neurogenic/drug therapy
Chemical Substances	Botulinum Toxins, Type A (EC 3.4.24.69) ; onabotulinum toxin A (EC 3.4.24.69)
Language	English
Publishing date	2020-12-11
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	604904-7
ISSN	1520-6777 ; 0733-2467
ISSN (online)	1520-6777
ISSN	0733-2467
DOI	10.1002/nau.24588
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Article ; Online: Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding.

Yuan, Jiacheng / Radecki, Daniel / Bugarin, Denise / Geib, Till / Zhou, Jihao / Liu, Jeen

Contemporary clinical trials communications

2018 Volume 11, Page(s) 83–88

Abstract: This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed ... ...

Abstract	This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations.
Language	English
Publishing date	2018-06-18
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2018.06.006
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Article ; Online: Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding

Jiacheng Yuan / Daniel Radecki / Denise Bugarin / Till Geib / Jihao Zhou / Jeen Liu

Contemporary Clinical Trials Communications, Vol 11, Iss , Pp 83-

2018 Volume 88

Abstract	This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations. Keywords: Adaptive design, Dose finding, Proof of concept, Seamless design, Budget saving
Keywords	Medicine (General) ; R5-920
Language	English
Publishing date	2018-09-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Restoration of full-length SMN promoted by adenoviral vectors expressing RNA antisense oligonucleotides embedded in U7 snRNAs.

Geib, Till / Hertel, Klemens J

PloS one

2009 Volume 4, Issue 12, Page(s) e8204

Abstract: Background: Spinal Muscular Atrophy (SMA) is an autosomal recessive disease that leads to specific loss of motor neurons. It is caused by deletions or mutations of the survival of motor neuron 1 gene (SMN1). The remaining copy of the gene, SMN2, ... ...

Abstract	Background: Spinal Muscular Atrophy (SMA) is an autosomal recessive disease that leads to specific loss of motor neurons. It is caused by deletions or mutations of the survival of motor neuron 1 gene (SMN1). The remaining copy of the gene, SMN2, generates only low levels of the SMN protein due to a mutation in SMN2 exon 7 that leads to exon skipping. Methodology/principal findings: To correct SMN2 splicing, we use Adenovirus type 5-derived vectors to express SMN2-antisense U7 snRNA oligonucleotides targeting the SMN intron 7/exon 8 junction. Infection of SMA type I-derived patient fibroblasts with these vectors resulted in increased levels of exon 7 inclusion, upregulating the expression of SMN to similar levels as in non-SMA control cells. Conclusions/significance: These results show that Adenovirus type 5-derived vectors delivering U7 antisense oligonucleotides can efficiently restore full-length SMN protein and suggest that the viral vector-mediated oligonucleotide application may be a suitable therapeutic approach to counteract SMA.
MeSH term(s)	Adenoviridae/genetics ; Alternative Splicing/genetics ; Base Sequence ; Fibroblasts/metabolism ; Fibroblasts/pathology ; Genetic Therapy ; Genetic Vectors/genetics ; HeLa Cells ; Humans ; Molecular Sequence Data ; Oligonucleotides, Antisense/genetics ; RNA, Small Nuclear/genetics ; Survival of Motor Neuron 1 Protein/genetics
Chemical Substances	Oligonucleotides, Antisense ; RNA, Small Nuclear ; Survival of Motor Neuron 1 Protein ; U7 small nuclear RNA
Language	English
Publishing date	2009-12-08
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0008204
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Article ; Online: Restoration of full-length SMN promoted by adenoviral vectors expressing RNA antisense oligonucleotides embedded in U7 snRNAs.

Till Geib / Klemens J Hertel

PLoS ONE, Vol 4, Iss 12, p e

2009 Volume 8204

Abstract: BACKGROUND:Spinal Muscular Atrophy (SMA) is an autosomal recessive disease that leads to specific loss of motor neurons. It is caused by deletions or mutations of the survival of motor neuron 1 gene (SMN1). The remaining copy of the gene, SMN2, generates ...

Abstract	BACKGROUND:Spinal Muscular Atrophy (SMA) is an autosomal recessive disease that leads to specific loss of motor neurons. It is caused by deletions or mutations of the survival of motor neuron 1 gene (SMN1). The remaining copy of the gene, SMN2, generates only low levels of the SMN protein due to a mutation in SMN2 exon 7 that leads to exon skipping. METHODOLOGY/PRINCIPAL FINDINGS:To correct SMN2 splicing, we use Adenovirus type 5-derived vectors to express SMN2-antisense U7 snRNA oligonucleotides targeting the SMN intron 7/exon 8 junction. Infection of SMA type I-derived patient fibroblasts with these vectors resulted in increased levels of exon 7 inclusion, upregulating the expression of SMN to similar levels as in non-SMA control cells. CONCLUSIONS/SIGNIFICANCE:These results show that Adenovirus type 5-derived vectors delivering U7 antisense oligonucleotides can efficiently restore full-length SMN protein and suggest that the viral vector-mediated oligonucleotide application may be a suitable therapeutic approach to counteract SMA.
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2009-12-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Substitutent effects in the periphery of 2,9-bisaryl-tetraazaperopyrene dyes.

Martens, Susanne C / Riehm, Till / Geib, Sonja / Wadepohl, Hubert / Gade, Lutz H

The Journal of organic chemistry

2011 Volume 76, Issue 2, Page(s) 609–617

Abstract: A series of 2,9-bisaryl-1,3,8,10-tetraazaperopyrene (TAPP) derivatives has been synthesized by reacting 4,9-diamino-3,10-perylenequinone diimine with a large excess of the corresponding benzoyl chloride in refluxing nitrobenzene. Among all derivatives ... ...

Abstract	A series of 2,9-bisaryl-1,3,8,10-tetraazaperopyrene (TAPP) derivatives has been synthesized by reacting 4,9-diamino-3,10-perylenequinone diimine with a large excess of the corresponding benzoyl chloride in refluxing nitrobenzene. Among all derivatives only ortho-substituted phenyl congeners were sufficiently soluble for studying solutions of defined concentration in organic solvents. The molecular structures of the crystallized compounds, determined by X-ray diffraction of four derivatives, are determined by the planar tetraazaperopyrene core and the interplanar angle of the phenyl rings, which depends on the size of the ortho substituent (40-70°). The intermolecular packing pattern of all compounds is characterized by parallel stacks of molecules with the substituted phenyl rings rotated out of the peropyrene plane to reduce the steric repulsion. Crystals of a TAPP derivative suitable for X-ray diffraction were grown from trifluoroacetic acid (TFA) for the first time, establishing a 2-fold protonated species. The ground-state geometries of the TAPP derivatives were calculated by DFT [B3PW91/6-31g(d,p)] and the lowest unoccupied molecular orbital (LUMO) energies of derivatives possessing electron-withdrawing groups were decreased, as were the computed electron affinities. The results of the modeling study were confirmed experimentally by cyclic voltammetry to evaluate the substituent effects on the highest occupied molecular orbital (HOMO) and the LUMO of the peropyrene core. The UV-vis absorption spectra of all compounds recorded in trifluoroacetic acid are almost superimposable and display a characteristic visible absorption band between 460 and 490 nm (log ε = 4.64-5.01) with a strong vibrational progression of 1173-1475 cm(-1). Their fluorescence spectra are characterized by bands between 490 and 530 nm that are the mirror images of the absorption spectra (Stokes shifts of 10-50 nm). The luminescence quantum yields range from <0.01 to 0.30, thereby indicating a quenching effect for some substitution patterns.
Language	English
Publishing date	2011-01-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	123490-0
ISSN	1520-6904 ; 0022-3263
ISSN (online)	1520-6904
ISSN	0022-3263
DOI	10.1021/jo102141w
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