Clinical trials: Intrathecal Drug Delivery
Amyotrophic Lateral Sclerosis
A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)
The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to <80 years of age with ALS who carry superoxide…
- Trial name
- ARMOR (NCT07290062)
- Testing
- INS1202
- Where
- 7 sites in United States
- Volunteers
- 23 people
- Sponsor
- Insmed Gene Therapy LLC
Chronic Pain
Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects
This study compares two different ways to treat pain. The two ways are: 1. continuing to take current pain medication(s) or 2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is…
- Trial name
- CONVERT-TDD (NCT01924182)
- Testing
- SynchroMed Infusion System and Intrathecal Morphine Sulfate, Conventional Medicine
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- MedtronicNeuro
Mucopolysaccharidosis (MPS)
Safety, Tolerability, Ascending Dose and Dose Frequency Study of rhHNS Via an IDDD in MPS IIIA Patients
Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease (LSD) caused by loss in activity of 1 of 4 enzymes necessary for degradation of the glycosaminoglycan (GAG) heparan sulfate (HS) in…
- Trial name
- NCT01155778
- Testing
- Recombinant human heparan N-sulfatase (rhHNS)
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Shire
Rett Syndrome
A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
The primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the…
- Trial name
- NCT05606614
- Testing
- TSHA-102
- Where
- 9 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Taysha Gene Therapies, Inc.
Management of Chronic Pain
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
- Trial name
- NCT01709721
- Testing
- Hydromorphone Hydrochloride, Programmable Implantable pump
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Piramal Critical Care, Ltd.
Type 2 Spinal Muscular Atrophy
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
This was a Phase III multi-center, single dose (1.2 x 10^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never…
- Trial name
- STEER (NCT05089656)
- Testing
- OAV101
- Where
- 42 sites in United States, Brazil and 11 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals