Niemann-Pick Disease, Type C1Phase 3TransportNPCNCT04860960
Phase 3 Study to Evaluate Intravenous Trappsol(R) Cyclo(TM) in Pediatric and Adult Patients With Niemann-Pick Disease Type C1
A Phase 3 study testing Hydroxypropyl-beta-cyclodextrin in people with Niemann-Pick Disease, Type C1, run by Cyclo Therapeutics, Inc. at 35 sites in 13 countries.
Trial summary
A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Niemann-Pick Disease, Type C1
- What is being tested?
- Hydroxypropyl-beta-cyclodextrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 35 sitesin 13 countries
- Study dates
- 20 Jul 2021to Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of NPC1
- Annual Severity Increment Score between 0.5 and 2.0 using the 17-domain NPC Severity Scale
- Treated or Not Treated with Miglustat (patients must be on a stable dose for at least 3 months prior to the Screening Visit, or have discontinued Miglustat for at least 3 months prior to Screening Visit).
- Body weight greater than 4.5 kg and less than or equal to 125 kg
- Presenting at least 1 neurological symptom of the disease
- Written informed consent
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- Willing and capable to participate in all aspects of trial design
- Ability to travel to the trial site at scheduled times
- Contraception requirements per protocol
- Caregiver consent as appropriate to participate in all protocol-specified assessments for duration of trial
- Inclusion criteria for Open Label Extension are 1) Received double-blind treatment for at least 48 weeks with CGI-S deterioration by at least 2 levels for 2 consecutive assessment visits 12 weeks apart, or 2) completion of double-blind treatment and completed all assessments through week 96, or 3) Discontinued early from double-blind treatment but completed all assessments through week 96
- Inclusion criteria for patients age 0 to 3 years in open-label sub-study in countries following EMA guidance only: Confirmed diagnosis of NPC1; treated or not with Miglustat per main study; body weight greater than 4.5kg; patient may be asymptomatic; written assent for child to participate in safety assessments; caregiver consent to participate in caregiver assessments; ability to travel to the trial site for all scheduled visits.
Who cannot join
- Recipient of a liver transplant within <12 months or planned liver transplantation
- Patients with active liver disease from any cause other than NPC1
- Clinical evidence of acute liver disease including symptoms of jaundice or right upper quadrant pain or international normalized ratio > 1.8
- Stage 3 chronic kidney disease or worse as indicated by an estimated glomerular filtration rate <60ml/min/1.73m2.
- Use of curcumin or fish oil within 12 weeks prior to enrollment
- Known or suspected allergy or intolerance to the study treatment
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- In the opinion of the Investigator, the patient's clinical condition does not allow for the blood collection required as per protocol specific procedures.
- Treatment with any investigational drug during the 3 months prior to entering the study. If the investigational drug has a short half-life (<8 hours) and would be expected to be cleared from the body within 1 month, then the wash-out period is 1 month. Treatment with any form of leucine, whether as an investigational drug or other formulation is not allowed
- Treatment with any other investigational drug during the study
- Pregnancy or breastfeeding
- Current participation in another trial is not permitted unless it is a noninterventional study and the sole purpose of the trial is for long-term follow up describing clinical features or survival data (registry)
- Patients with uncontrolled, severe epileptic seizure periods (at least 3 consecutive severe epileptic seizures that required medication) within 2 months prior to completion of informed consent or assent, as applicable.
- Neurologically asymptomatic patients
- Inability to participate in the primary study assessment (4D-NPC-SS or 5D-NPC-SS) as determined by the Investigator
- Exclusion criteria for patients age 0 to 3 years in open-label sub-study in countries following EMA guidance only are similar to the main study with the addition of exclusion criterion of history of fetal hydrops or fetal ascites
Trial locations and contacts
35 sites in 13 countries.
35 sites in 13 countries
United States7 sites
Emory
Atlanta, Georgia, 30322
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Lysosomal and Rare Disorders Research & Treatment Center, Inc.
Fairfax, Virginia, 22030
University of Florida
Jacksonville, Florida, 32207
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
UPMC Children's Hospital
Pittsburgh, Pennsylvania, 15224
University Utah
Salt Lake City, Utah, 84108
Italy4 sites
University of Catania
Catania
Istituto Neurologico Carlo Besta
Milan
University Hospital of Padova
Padova
Centro di Coordinamento Regionale Malattie Rare
Udine
Australia3 sites
Metabolic Clinical Trials Unit
Adelaide
Melbourne Children's Trials Centre Murdoch Children's Research Institute
Parkville, Victoria
Royal Melbourne Hospital
Parkville, Victoria
Brazil3 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre
Universidade de São Paulo
São Paulo
University of Campinas
São Paulo
Spain3 sites
Hospital Sant Joan de Déu - Neurology Department
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitario 12 de Octubre
Madrid
United Kingdom3 sites
Birmingham Children's Hospital NHS Foundation Trust · Department of Inherited Metabolic Disorders Service
Birmingham
University College London
London
Salford Royal Foundation NHS Trust
Salford
Argentina2 sites
Hospital de Alta Complejidad en Red "El Cruce"
Buenos Aires
Hospital de Niños de la Santísima Trinidad
Córdoba
Israel2 sites
Emek Medical Center-Department of Pediatrics
Afula
Soroka Medical Center
Beersheba
Turkey (Türkiye)2 sites
Gazi University Faculty of Medicine
Ankara
Ege University Medical School, Department of Inborn Errors of Metabolism
Izmir
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Centre
Riyadh
About this study
Official title: Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of 2000mg/kg of Trappsol®Cyclo™ (Hydroxypropyl-B-cyclodextrin) and Standard of Care Compared to Placebo and Standard of Care in Patients With Niemann-Pick Disease Type C1 (TransportNPC)
A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1). The objective of this study is to evaluate the safety, tolerability and efficacy of 2000 mg/kg dose of Trappsol Cyclo (hydroxypropyl betacyclodextrin) administered intravenously compared to standard of care. An open-label sub-study in countries following European Medicines Agency (EMA) guidance will enroll asymptomatic or symptomatic patients from infancy up to age 3 to evaluate safety in that population.
Read the detailed description
The TransportNPC study is a prospective, randomized, double-blind, placebo controlled therapeutic study for 93 patients age 3 and older with confirmed diagnosis of NPC1. The objective of this study is to evaluate the safety, tolerability and efficacy of 2000 mg/kg dose of Trappsol Cyclo (hydroxypropyl betacyclodextrin) administered intravenously by slow infusion every two weeks in addition to standard of care as compared to placebo and standard of care. Standard of care may include Miglustat or leucine products that are not currently under investigation as a therapeutic. Patients will be randomized to receive Trappsol Cyclo or placebo at a 2:1 ratio. The study duration is 96 weeks, with an unblinded interim analysis at 48 weeks. An open-label extension of up to 96 weeks follows the interventional study. Patients whose disease progression worsens by two levels in the Clinical Global Impression of Severity scale over 12 weeks, starting at week 36, may be moved to open label treatment. Efficacy will be measured at week 48 and week 96 by a composite score of major disease features. A sub-study will be conducted in countries following EMA guidance for up to 12 patients age 0 - 3 years who may be asymptomatic. Outcomes for the sub-study are safety, clinical and caregiver impression of disease.
- Conditions
- Niemann-Pick Disease, Type C1
- Being tested
- Hydroxypropyl-beta-cyclodextrin, Placebo
- Keywords
- NPC1, cyclodextrin, Niemann-Pick, Niemann-Pick Type C, NPC, Niemann Pick C, Niemann Pick Type C, Niemann Pick
- Medical subject headings
- Niemann-Pick Disease, Type C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxypropyl-beta-cyclodextrinDrug
Also called Trappsol Cyclo
Dose is 2000 mg/kg body weight provided every 2 weeks intravenously
PlaceboDrug
Also called 0.5N saline
0.5N saline provided every 2 weeks intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intravenous administration of 2000 mg/kg hydroxypropyl betacyclodextrin (Trappsol Cyclo) (based on body weight) diluted with 0.5N saline over at least 6.5 hours every 2 weeks Receives: Drug: Hydroxypropyl-beta-cyclodextrin |
| Placebo comparator | Placebo comparator | Intravenous administration of 0.5N saline over at least 6.5 hours every 2 weeks Receives: Drug: Placebo |
| Open Label sub-study for Infants up to age 3 | Experimental | Up to 12 patients age 0 - 3 yrs in countries following EMA guidance may be enrolled in this open label sub-study. All patients will receive 2000 mg/kg hydroxypropyl betacyclodextrin (Trappsol Cyclo) diluted with 0.5N saline at the clinician's discretion over 6.5 hours every 2 weeks. Outcome measures are safety, clinician and caregiver impressions. Receives: Drug: Hydroxypropyl-beta-cyclodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 4-Domain NPC Severity Score (US only)
Ambulation, Fine Motor, Speech, Swallow
Measured: Interim Analysis at Week 48
Change from Baseline in 4-Domain NPC Severity Score (US only)
Ambulation, Fine Motor, Speech, Swallow
Measured: End of Study at Week 96
Change from Baseline in 5-Domain NPC Severity Score (ex-US)
Ambulation, Fine Motor, Speech, Swallow, Cognition
Measured: Interim Analysis at Week 48
Change from Baseline in 5-Domain NPC Severity Score (ex-US)
Ambulation, Fine Motor, Speech, Swallow, Cognition
Measured: End of Study at Week 96
Secondary outcomes (4)
Change in ataxia as measured by Spinocerebellar ataxia functional index
SCAFI
Measured: Change from Baseline as measured every 12 weeks through week 96 and end of OLE week 192
Change in adaptive behavior as measured by Vineland Adaptive Behavior Scale II
Vineland Adaptive Behavior Scale II
Measured: Change from Baseline as measured every 12 weeks through week 96 and end of OLE week 192
Change in Swallow function evaluated by videofluoroscopy or fiberoptic endoscopy and measured by Penetration Aspiration Scale
PAS
Measured: Change from Baseline measured at Interim Analysis Week 48
Change in Swallow function evaluated by videofluoroscopy or fiberoptic endoscopy and measured by Penetration Aspiration Scale
PAS
Measured: Change from Baseline measured at End of Study Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start20 Jul 2021
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Niemann-Pick Disease, Type C1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, multi-center, double-blind and parallel group study with 2:1 randomization of Trappsol Cyclo plus SOC versus placebo plus SOC over 96 weeks, followed by open-label extension study of 96 weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Mullen, MD, Study director, Cyclo Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860960
- Sponsor's protocol ID
- CTD-TCNPC-301
- Acronym
- TransportNPC
- Status last verified
- Sep 2023
- First submitted
- 15 Apr 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hastings C, Liu B, Hurst B, Cox GF, Hrynkow S. Intravenous 2-hydroxypropyl-beta-cyclodextrin (Trappsol(R) Cyclo) demonstrates biological activity and impacts cholesterol metabolism in the central nervous system and peripheral tissues in adult subjects with Niemann-Pick Disease Type C1: Results of a phase 1 trial. Mol Genet Metab. 2022 Dec;137(4):309-319. doi: 10.1016/j.ymgme.2022.10.004. Epub 2022 Oct 17.
PubMed 36279795
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of 2000mg/kg of Trappsol®Cyclo™ (Hydroxypropyl-B-cyclodextrin) and Standard of Care Compared to Placebo and Standard of Care in Patients With Niemann-Pick Disease Type C1 (TransportNPC)
- ClinicalTrials.gov ID
- NCT04860960
- Acronym / sponsor ID
- TransportNPC / CTD-TCNPC-301
- Conditions
- Niemann-Pick Disease, Type C1
- Keywords
- NPC1, cyclodextrin, Niemann-Pick, Niemann-Pick Type C, NPC, Niemann Pick C, Niemann Pick Type C, Niemann Pick
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cyclo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1). The objective of this study is to evaluate the safety, tolerability and efficacy of 2000 mg/kg dose of Trappsol Cyclo (hydroxypropyl betacyclodextrin) administered intravenously compared to standard of care. An open-label sub-study in countries following European Medicines Agency (EMA) guidance will enroll asymptomatic or symptomatic patients from infancy up to age 3 to evaluate safety in that population.
Detailed description
The TransportNPC study is a prospective, randomized, double-blind, placebo controlled therapeutic study for 93 patients age 3 and older with confirmed diagnosis of NPC1. The objective of this study is to evaluate the safety, tolerability and efficacy of 2000 mg/kg dose of Trappsol Cyclo (hydroxypropyl betacyclodextrin) administered intravenously by slow infusion every two weeks in addition to standard of care as compared to placebo and standard of care. Standard of care may include Miglustat or leucine products that are not currently under investigation as a therapeutic. Patients will be randomized to receive Trappsol Cyclo or placebo at a 2:1 ratio. The study duration is 96 weeks, with an unblinded interim analysis at 48 weeks. An open-label extension of up to 96 weeks follows the interventional study. Patients whose disease progression worsens by two levels in the Clinical Global Impression of Severity scale over 12 weeks, starting at week 36, may be moved to open label treatment. Efficacy will be measured at week 48 and week 96 by a composite score of major disease features. A sub-study will be conducted in countries following EMA guidance for up to 12 patients age 0 - 3 years who may be asymptomatic. Outcomes for the sub-study are safety, clinical and caregiver impression of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, multi-center, double-blind and parallel group study with 2:1 randomization of Trappsol Cyclo plus SOC versus placebo plus SOC over 96 weeks, followed by open-label extension study of 96 weeks
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Hydroxypropyl-beta-cyclodextrinIntravenous administration of 2000 mg/kg hydroxypropyl betacyclodextrin (Trappsol Cyclo) (based on body weight) diluted with 0.5N saline over at least 6.5 hours every 2 weeks |
| Placebo comparator | Placebo comparator | Drug: PlaceboIntravenous administration of 0.5N saline over at least 6.5 hours every 2 weeks |
| Open Label sub-study for Infants up to age 3 | Experimental | Drug: Hydroxypropyl-beta-cyclodextrinUp to 12 patients age 0 - 3 yrs in countries following EMA guidance may be enrolled in this open label sub-study. All patients will receive 2000 mg/kg hydroxypropyl betacyclodextrin (Trappsol Cyclo) diluted with 0.5N saline at the clinician's discretion over 6.5 hours every 2 weeks. Outcome measures are safety, clinician and caregiver impressions. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed diagnosis of NPC1
- Annual Severity Increment Score between 0.5 and 2.0 using the 17-domain NPC Severity Scale
- Treated or Not Treated with Miglustat (patients must be on a stable dose for at least 3 months prior to the Screening Visit, or have discontinued Miglustat for at least 3 months prior to Screening Visit).
- Body weight greater than 4.5 kg and less than or equal to 125 kg
- Presenting at least 1 neurological symptom of the disease
Key exclusion criteria (15 listed)
- Recipient of a liver transplant within <12 months or planned liver transplantation
- Patients with active liver disease from any cause other than NPC1
- Clinical evidence of acute liver disease including symptoms of jaundice or right upper quadrant pain or international normalized ratio > 1.8
- Stage 3 chronic kidney disease or worse as indicated by an estimated glomerular filtration rate <60ml/min/1.73m2.
- Use of curcumin or fish oil within 12 weeks prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxypropyl-beta-cyclodextrinAlso: Trappsol CycloDose is 2000 mg/kg body weight provided every 2 weeks intravenously | Drug | Experimental, Open Label sub-study for Infants up to age 3 |
| PlaceboAlso: 0.5N saline0.5N saline provided every 2 weeks intravenously | Drug | Placebo comparator |
Primary outcome
Change from Baseline in 4-Domain NPC Severity Score (US only)
Time frame: Interim Analysis at Week 48
Ambulation, Fine Motor, Speech, Swallow
Change from Baseline in 4-Domain NPC Severity Score (US only)
Time frame: End of Study at Week 96
Ambulation, Fine Motor, Speech, Swallow
Change from Baseline in 5-Domain NPC Severity Score (ex-US)
Time frame: Interim Analysis at Week 48
Ambulation, Fine Motor, Speech, Swallow, Cognition
Change from Baseline in 5-Domain NPC Severity Score (ex-US)
Time frame: End of Study at Week 96
Ambulation, Fine Motor, Speech, Swallow, Cognition
4 secondary outcomes
Change in ataxia as measured by Spinocerebellar ataxia functional index
Time frame: Change from Baseline as measured every 12 weeks through week 96 and end of OLE week 192
Change in adaptive behavior as measured by Vineland Adaptive Behavior Scale II
Time frame: Change from Baseline as measured every 12 weeks through week 96 and end of OLE week 192
Change in Swallow function evaluated by videofluoroscopy or fiberoptic endoscopy and measured by Penetration Aspiration Scale
Time frame: Change from Baseline measured at Interim Analysis Week 48
Change in Swallow function evaluated by videofluoroscopy or fiberoptic endoscopy and measured by Penetration Aspiration Scale
Time frame: Change from Baseline measured at End of Study Week 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 36279795Hastings C, Liu B, Hurst B, Cox GF, Hrynkow S. Intravenous 2-hydroxypropyl-beta-cyclodextrin (Trappsol(R) Cyclo) demonstrates biological activity and impacts cholesterol metabolism in the central nervous system and peripheral tissues in adult subjects with Niemann-Pick Disease Type C1: Results of a phase 1 trial. Mol Genet Metab. 2022 Dec;137(4):309-319. doi: 10.1016/j.ymgme.2022.10.004. Epub 2022 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Mullen, MD study director
Cyclo Therapeutics, Inc.
35 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxypropyl-beta-cyclodextrin in people with Niemann-Pick Disease, Type C1, run by Cyclo Therapeutics, Inc. at 35 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Italy, Australia, Brazil, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 4-Domain NPC Severity Score (US only) (time frame: Interim Analysis at Week 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.