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Progressive Supranuclear PalsyPhase 1NCT02494024

Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy

A Phase 1 study testing Single dose C2N-8E12 in people with Progressive Supranuclear Palsy, run by C2N Diagnostics at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with progressive supranuclear palsy (PSP). Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Progressive Supranuclear Palsy
What is being tested?
Single dose C2N-8E12
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
12 sitesUnited States
Study dates
Jul 2015to Aug 2016
Phase
Phase 1
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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets NINDS-SPSP possible or probable criteria as modified for NNIPPS and AL-108-231 clinical trials
  • Brain MRI at Screening is consistent with PSP;
  • Stable medications for Parkinsonism for at least 2 months prior to Screening;
  • Agree to use protocol specified methods of contraception.

Who cannot join

  • Signs of a progressive neurological disorder that better meets the criteria for types of neurological disorders other than PSP;
  • Currently on any other biologic or immunomodulatory therapy;
  • Subjects that reside at a skilled nursing or dementia care facility;
  • Diagnosis of any other significant unrelated neurological or psychiatric disorders that could account for cognitive deficits;
  • Untreated major depression at baseline evaluation, based on clinical judgment and results in geriatric depression scale;
  • Unable to tolerate MRI scan at Screening or any other contraindication to MRI;
  • Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anti-coagulant medications.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Alabama

    Birmingham, Alabama, 35294

  • Texas Health Presbyterian Dallas

    Dallas, Texas, 75231

  • University of Florida College of Medicine

    Gainesville, Florida, 32607

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of California, Los Angeles (UCLA)

    Los Angeles, California, 90095

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2551

  • Columbia University

    New York, New York, 10032-3795

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UCSD Department of Neurosciences

    San Diego, California, 92037

  • University of California, San Francisco

    San Francisco, California, 94158

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy

This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with progressive supranuclear palsy (PSP).

Read the detailed description

This study evaluates the safety, tolerability, pharmacokinetics, and maximum tolerated dose (within dosing range) of intravenous (IV) infusion of C2N-8E12 in 32 patients with progressive supranuclear palsy (PSP). Four sequential cohorts will receive increasing single doses of either C2N-8E12 or placebo. Out of every 4 patients enrolled 3 patients will receive drug and 1 will receive placebo. Study participants will be followed for a minimum of 2 months post-treatment to monitor for the safety, tolerability, pharmacokinetics, and immunogenicity of C2N-8E12.

Being tested
Single dose C2N-8E12, Single dose placebo
Keywords
PSP, C2N-8E12, tauopathy, Progressive Supranuclear Palsy, Steele Richardson Olszewski Syndrome, Humanized anti-tau antibody
Medical subject headings
Supranuclear Palsy, Progressive, Tauopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single dose C2N-8E12Drug

    C2N-8E12 is a humanized recombinant anti-human tau antibody.

  • Single dose placeboDrug

    Subjects will be block randomized to receive a single dose of C2N-8E12 or placebo in two blocks of 4 subjects (3:1, C2N-8E12:placebo) per cohort.

Study groups in NCT02494024
Study groupRoleWhat they receive
Single dose C2N-8E12 level 1ExperimentalSingle IV infusion of C2N-8E12
Receives: Drug: Single dose C2N-8E12
Single dose C2N-8E12 level 2ExperimentalSingle IV infusion of C2N-8E12
Receives: Drug: Single dose C2N-8E12
Single dose C2N-8E12 level 3ExperimentalSingle IV infusion of C2N-8E12
Receives: Drug: Single dose C2N-8E12
Single dose C2N-8E12 level 4ExperimentalSingle IV infusion of C2N-8E12
Receives: Drug: Single dose C2N-8E12
Single dose placeboPlacebo comparatorSingle IV infusion of placebo
Receives: Drug: Single dose placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability, as measured by number of participants experiencing adverse events (AEs), serious AEs, and abnormalities in clinical laboratory tests, vital signs, ECGs, MRI, and physical and neurological exams.

    Measured: up to 4 months

Secondary outcomes (3)

  1. Immunogenicity as measured by the number of participants developing anti drug antibodies.

    Measured: up to 4 months

  2. Area under the concentration vs time curve (AUC) of C2N-8E12

    Measured: up to 4 months

  3. Elimination half-life of C2N-8E12

    Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02494024
Sponsor's protocol ID
C2N-8E12-WW-104
Status last verified
Jul 2017
First submitted
30 Jun 2015
Last updated
26 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Yanamandra K, Kfoury N, Jiang H, Mahan TE, Ma S, Maloney SE, Wozniak DF, Diamond MI, Holtzman DM. Anti-tau antibodies that block tau aggregate seeding in vitro markedly decrease pathology and improve cognition in vivo. Neuron. 2013 Oct 16;80(2):402-414. doi: 10.1016/j.neuron.2013.07.046. Epub 2013 Sep 26.

    PubMed 24075978

  • Boxer AL, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Golbe LI, Williams DR, Corvol JC, Ludolph A, Burn D, Lorenzl S, Litvan I, Roberson ED, Hoglinger GU, Koestler M, Jack CR Jr, Van Deerlin V, Randolph C, Lobach IV, Heuer HW, Gozes I, Parker L, Whitaker S, Hirman J, Stewart AJ, Gold M, Morimoto BH; AL-108-231 Investigators. Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial. Lancet Neurol. 2014 Jul;13(7):676-85. doi: 10.1016/S1474-4422(14)70088-2. Epub 2014 May 27.

    PubMed 24873720

  • Litvan I, Agid Y, Calne D, Campbell G, Dubois B, Duvoisin RC, Goetz CG, Golbe LI, Grafman J, Growdon JH, Hallett M, Jankovic J, Quinn NP, Tolosa E, Zee DS. Clinical research criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome): report of the NINDS-SPSP international workshop. Neurology. 1996 Jul;47(1):1-9. doi: 10.1212/wnl.47.1.1.

    PubMed 8710059

  • Yanamandra K, Jiang H, Mahan TE, Maloney SE, Wozniak DF, Diamond MI, Holtzman DM. Anti-tau antibody reduces insoluble tau and decreases brain atrophy. Ann Clin Transl Neurol. 2015 Mar;2(3):278-88. doi: 10.1002/acn3.176. Epub 2015 Jan 23.

    PubMed 25815354

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Single dose C2N-8E12 in people with Progressive Supranuclear Palsy, run by C2N Diagnostics at 12 sites 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability, as measured by number of participants experiencing adverse events (AEs), serious AEs, and abnormalities in clinical laboratory tests, vital signs, ECGs, MRI, and physical and neurological exams. (time frame: up to 4 months). 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 NCT02494024, which also lists 4 linked publications.

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 26 Jul 2017.

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