Multiple SclerosisPhase 2/3RECLAIMNCT00947895
Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone
A Phase 2/3 study testing Methylprednisolone and ACTH in people with Multiple Sclerosis, run by Neurologique Foundation, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Methylprednisolone and ACTH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2011
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female
- females of childbearing potential must:
- have negative pregnancy tests prior to entry into the Double-blind Treatment Phase
- agree to use adequate contraception during the treatment.
- females who are either post-menopausal for 12 months prior to randomization or surgically sterile (if documented), may be included without above requirements
- ≥ 18 years of age
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- sign written informed consent prior to participating in the study (Appendix 1)
- willing and able to comply with trial requirements, including visit schedule and completion of scales
- diagnosis of multiple sclerosis by 2005 revised McDonald criteria (Appendix 3)
- an Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive
- currently taking a stable dose of an injectable MS disease modifying agent for the preceding 6 months or greater prior to the study-entry relapse
- in the opinion of their treating physician should undergo a 3 - 5 day course of IV methylprednisolone
Who cannot join
- a manifestation of MS other than relapsing
- initial IV MP greater than 14 days after from start of presenting relapse
- a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
- a known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [≥126 mg/dL or ≥7 mmol/L if fasting; ≥200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
- a contraindication to steroid therapy, e.g., peptic ulcer, psychotic states or severe hypertension
- sensitivity to proteins of porcine origin
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- a known or 'new' diagnosis of severe depression as defined by a score greater than 30 on the Beck Depression Inventory (BDI)
- a known or 'new' diagnosis of hypothyroidism not adequately controlled with medication
- treatment with Natalizumab in the past 6 months
- active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
- have received total lymphoid irradiation or bone marrow transplantation
- have been treated with corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to Pre-Randomization Phase
- any medically unstable condition, as assessed by the primary treating physician
- any of the following neurologic/psychiatric disorders:
- history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
- progressive neurological disorder, other than MS, which may affect participation in the study or require the use of medications not allowed by the protocol
- any of the following abnormal laboratory values:
- serum creatinine greater than 1.7 mg/dL (150 μmol/L)
- white blood cell (WBC) count <3,500/mm3 (<3.5 X 109 / L)
- lymphocyte count <800/mm3 (<0.8 X 109 / L)
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurologique Foundation, Inc.
Ponte Vedra, Florida, 32082
About this study
Official title: Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study
The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone.
- Conditions
- Multiple Sclerosis
- Being tested
- Methylprednisolone, ACTH, IV placebo, IM placebo
- Keywords
- ACTH, Acthar gel, adrenocorticotropin, methylprednisolone, solumedrol, MS, multiple, sclerosis, relapse, exacerbation, sub-responsive, IV
- Medical subject headings
- Multiple Sclerosis, Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solumedrol
IV 1000 mg daily for 3 days
ACTHDrug
Also called H.P. Acthar Gel, Repository corticotropin injection, Adrenocorticotropin hormone
IM ACTH 80 mg/day for 5 days.
IV placeboOther
IV placebo (saline) daily for 3 days.
IM placeboOther
IM placebo (saline) daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days. Receives: Drug: Methylprednisolone; Other: IM placebo |
| ACTH | Active comparator | Intramuscular (IM) ACTH 80 mg/day for 5 days. Receives: Drug: ACTH; Other: IV placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).
Measured: 12 weeks
Secondary outcomes (2)
Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.
Measured: 12 weeks
Safety and tolerability of ACTH and MP in patients with an acute relapse of multiple sclerosis after sub-response to an initial course of intravenous methylprednisolone.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Study reached halfway point in approximately one year time period and was halted to analyze data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurologique Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Daniel Kantor, MD, Principal investigator, Neurologique Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947895
- Sponsor's protocol ID
- Q1001
- Acronym
- RECLAIM
- Status last verified
- Mar 2016
- First submitted
- 2 Jul 2009
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT00947895
- Acronym / sponsor ID
- RECLAIM / Q1001
- Conditions
- Multiple Sclerosis
- Keywords
- ACTH, Acthar gel, adrenocorticotropin, methylprednisolone, solumedrol, MS, multiple, sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study reached halfway point in approximately one year time period and was halted to analyze data.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Neurologique Foundation, Inc.University, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jul 2009 (estimated)
- 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.
The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: Methylprednisolone, Other: IM placeboIntravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days. |
| ACTH | Active comparator | Drug: ACTH, Other: IV placeboIntramuscular (IM) ACTH 80 mg/day for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- male or female
- ≥ 18 years of age
- sign written informed consent prior to participating in the study (Appendix 1)
- willing and able to comply with trial requirements, including visit schedule and completion of scales
- diagnosis of multiple sclerosis by 2005 revised McDonald criteria (Appendix 3)
Key exclusion criteria (20 listed)
- a manifestation of MS other than relapsing
- initial IV MP greater than 14 days after from start of presenting relapse
- a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
- a known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [≥126 mg/dL or ≥7 mmol/L if fasting; ≥200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
- a contraindication to steroid therapy, e.g., peptic ulcer, psychotic states or severe hypertension
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 |
|---|---|---|
| MethylprednisoloneAlso: SolumedrolIV 1000 mg daily for 3 days | Drug | Methylprednisolone |
| ACTHAlso: H.P. Acthar Gel, Repository corticotropin injection, Adrenocorticotropin hormoneIM ACTH 80 mg/day for 5 days. | Drug | ACTH |
| IV placeboIV placebo (saline) daily for 3 days. | Other | ACTH |
| IM placeboIM placebo (saline) daily for 5 days. | Other | Methylprednisolone |
Primary outcome
Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).
Time frame: 12 weeks
2 secondary outcomes
Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.
Time frame: 12 weeks
Safety and tolerability of ACTH and MP in patients with an acute relapse of multiple sclerosis after sub-response to an initial course of intravenous methylprednisolone.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study reached halfway point in approximately one year time period and was halted to analyze data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Study sponsor websiteLink provided by the sponsor.
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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.
Daniel Kantor, MD principal investigator
Neurologique Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylprednisolone and ACTH in people with Multiple Sclerosis, run by Neurologique Foundation, Inc. at 1 site in United States.
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 20 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: stopped early, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study was stopped early (reason given: Study reached halfway point in approximately one year time period and was halted to analyze data.). 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?
Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities). (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2016.